MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Menstrual Irregularities (1959); Abdominal Cramps (2543); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting, which took place in september 2015 (fda-2014-n-0736-2578, awareness date 02-nov-2015).It refers to a female consumer of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted in 2012.Consumer was (b)(6), mother of 3.Now she has had essure for 3 years.She has to have a total hysterectomy due to these horrific things.Last year, 2014, she passed part of a coil that broke into 3 pieces.Now she is having more issues with the rest of that coil missing.For 3 years she has had nonstop cramping, really bad periods, horrible migraines, plus many more issues.She has been daily living with pains that come with having these objects in her body.Quality assessment: in this case, no product sample was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect.Company causality comment: this spontaneous and non-medically confirmed case report refers to an adult female patient who had essure (fallopian tube occlusion insert) inserted and in the previous year to this report, she passed part of a coil that broke into 3 pieces.This event, seen as device breakage, is non-serious and listed in the reference safety information for essure.Single cases of device breakage have been reported.In spite of the lack of information regarding the circumstances of this breakage, considering its nature, the event is assesses as related to essure use.This case is assessed as other reportable incident since the breakage in this report did not lead to serious injury, however, it might have led under less fortunate circumstances.Other non-serious events were also informed.Based on the available information, there is no relationship between the reported events and a quality defect.No further follow up will be actively pursued, since this case was identified during health authority website monitoring.

Manufacturer Narrative

Follow up information received on 13-jun-2016: legal claim was received from a lawyer on behalf of the consumer/plaintiff.Essure was inserted on (b)(6) 2012.Shortly after undergoing the essure procedure, an hysterosalpingogram test was performed and plaintiff was advised that her coils were properly placed.However her post procedure period has been marked by increasingly severe pain and discomfort including heavy menstrual bleeding, chronic pelvic pain, chronic back pain and abdominal pain.Plaintiff never experienced any of these conditions prior to undergoing the essure procedure.She subsequently sought treatment for her symptoms from multiple physicians but was unable to resolve her symptoms.In or around (b)(6) 2014 she learned that one of her essure coils migrated out of her fallopian tube and broke apart.On or around (b)(6) 2015 plaintiff underwent an ultrasound which showed that one of her essure coils could not be visualized.On or around (b)(6) 2015, plaintiff underwent a hysterectomy to have the essure coils removed.Company causality comment: this non-medically confirmed, spontaneous case report refers to an adult female patient who had essure (fallopian tube occlusion insert) inserted and one of her essure coils migrated out of her fallopian tube and broke apart (coil broke into 3 pieces).She underwent a hysterectomy to remove the coils.These events are listed in the reference safety information for essure (device migration) and according to the technical analysis (device breakage).Device breakage and migration may occur during essure therapy.In spite of the lack of information regarding the circumstances of these events, considering their nature, they were assessed as related to essure use.This case was upgraded to incident after receipt of follow-up information, since device removal was required.Other non-serious events were also informed.Based on the available information, there is no relationship between the reported events and a quality defect.Upon receipt of follow-up information this case became legal, thus further information will be obtained through the litigation process.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one of her essure coils migrated out of her fallopian tube / one of her essure coils could not be visualized") and device breakage ("last year i passed part of a coil that broke into 3 pieces / broke apart") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal pain ("non stop cramping, pains that come with having these objects in her body / abdominal pain"), menstrual disorder ("really bad periods"), migraine ("horrible migraines"), pelvic pain ("severe pain / chronic pelvic pain"), pelvic discomfort ("discomfort"), menorrhagia ("heavy menstrual bleeding") and back pain ("chronic back pain").The patient was treated with surgery.Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage, abdominal pain, menstrual disorder, migraine, pelvic pain, pelvic discomfort, menorrhagia and back pain outcome was unknown.The reporter considered abdominal pain, back pain, device breakage, device dislocation, menorrhagia, menstrual disorder, migraine, pelvic discomfort and pelvic pain to be related to essure.Quality-safety evaluation of ptc: quality assessment: in this case, no product sample was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 6-jun-2017: quality safety evaluation of product technical complaint.Company causality comment: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This case was initially received via regulatory authority (reference number: fda-2014-n-0736-2578) on 02-nov-2015.The most recent information was received on 15-jan-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('one of her essure coils migrated out of her fallopian tube / one of her essure coils could not be visualized/pulled tampon and had spring attached to it ') and device breakage ('last year i passed part of a coil that broke into 3 pieces / broke apart/ spring attached to it/inner part is still located in tube and outer part came out') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 3.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal pain ("non stop cramping, pains that come with having these objects in her body / abdominal pain"), menstrual disorder ("really bad periods"), migraine ("horrible migraines"), pelvic pain ("severe pain / chronic pelvic pain"), pelvic discomfort ("discomfort"), menorrhagia ("heavy menstrual bleeding"), back pain ("chronic back pain") and abdominal pain lower ("cramp so bad its almost like labour pain").The patient was treated with surgery.Essure was removed on (b)(6) 2015.At the time of the report, the device expulsion, device breakage, abdominal pain, menstrual disorder, migraine, pelvic pain, pelvic discomfort, menorrhagia, back pain and abdominal pain lower outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, back pain, device breakage, device expulsion, menorrhagia, menstrual disorder, migraine, pelvic discomfort and pelvic pain to be related to essure.Quality-safety evaluation of ptc: quality assessment: in this case, no product sample was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 15-jan-2020: f\u 4 & 5 proceed together- social media received: newly added event- lower abdominal pain.Event dislocation was updated to expulsion.Reporter was added.On 16-jan-2020: social media received: reporter was added, no new clinically significant information were added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• MDR Report Key: 5257003
• MDR Text Key: 32381980
• Report Number: 2951250-2015-01779
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 06/06/2017
• Supplement Dates FDA Received: 07/06/2016; 01/20/2017; 06/15/2017; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention